Regenerative Outcomes Miami now offers affordable Clinical Trial Management Support service options, provided by its expert team based in Miami, Florida.
Nashville, TN, and Miami, FL, JUNE 15, 2021 — Regenerative Outcomes LLC, a Tennessee-based company providing regulatory application and translational development services to regenerative medicine biotechnology companies, expands operations outside of Nashville facilitates to its new location at popular South Beach, Miami, Florida.
Doug Oliver, MSW, Founder and President of Regenerative Outcomes, LLC, describes “Regenerative Outcomes Miami” as “an extension of our strategy in meeting the needs of a client base that would otherwise not have access to both domestic and foreign clinical trial capabilities, or the highly-specialized team to manage next steps in bringing their cell-based therapeutics and device innovations to help patients.”
Oliver also announced the appointment of Vidya Maharaj, MPH, as VP of Clinical Services and Development of Regenerative Outcomes Miami, who will lead the team, and continue Regenerative Outcomes’ mission of helping clients easily navigate the complex regulatory pathways in the niche industry of regenerative medicine.
“Florida was a sensible choice for us and our clients,” says Maharaj, “Doug and I already have a pipeline of prospective clients local to the Florida market. Miami is an optimal physical location to allow for us to meet these prospects face-to-face, building trust and a deeper personal connection. Miami is also known strategically and geographically as a hub for international expansion.”
“This feels like it is just the beginning of the next leg of the journey to get as many safe treatments out there to patients as we can, as quickly as possible, and Vidya has both the experience and skills to take it there,” says Oliver.
Clinical trial management is both costly, and competitive, and these financial challenges can dissuade smaller to mid-size regenerative medicine biotechnology companies from introducing potentially life-saving treatments to those in need.
“Our aim has always been to give a voice to those that can’t compete with the pricing standards set by Big Pharma” contends Maharaj. “It is unfortunate when a company is financially stranded and doesn’t have the adequate funds necessary to conduct a trial. Our collaborative model brings efficiencies and proprietary methods that will provide these companies an opportunity to do so by using an ‘all means possible’ approach. We need to help small stakeholders with big ideas bring their dreams to fruition.”
About Regenerative Outcomes, LLC
Regenerative Outcomes, LLC, [email protected], is located in Nashville, Tennessee, and is comprised of a global regenerative medicine team possessing deep subject matter expertise, FDA insight and scientific acumen.
The company has a finger directly on the pulse of regulatory reform and uses a full spectrum approach to provide turn-key regulatory services, indication and translational research assistance, IND preparation and submission, clinical protocol development, patient informed consent review, IRB matching, and more.
About Regenerative Outcomes Miami
Regenerative Outcomes Miami, [email protected], is based in Miami, Florida, and is committed to leading the way for small to mid-size biotechnology companies that seek affordable management and support services for domestic and foreign early phase clinical trials in regenerative medicine technologies.
The company initiates sponsors and manufacturers into trial preparation and related activities, and provides comprehensive oversight, site monitoring, data management, patient recruitment and retention, as well as other services.
Regenerative Outcomes Miami utilizes a collaboration model to bridge gaps in moving companies from regulatory application development and submission to conducting early phase clinical trials. The company’s management and support strategies brings unique and proprietary efficiencies, and measurable financial savings associated with that approach.